CDC: Yellow fever vaccine supply to be depleted in US by mid-2017

Infectious Disease News, May 2017

The CDC announced today that it is anticipating a complete depletion of the U.S. supply of YF-VAX — the only yellow fever vaccine licensed in the United States — by mid-2017.

In response, the CDC is collaborating with the vaccine’s manufacturer, Sanofi Pasteur, to distribute limited quantities of another yellow fever vaccine, Stamaril (Sanofi Pasteur France), that is not licensed in the U.S. However, the number of sites that will offer the vaccine will be significantly fewer than the number of sites that usually distribute YF-VAX.

According to an MMWR, the supply depletion of YF-VAX began in November 2015. Sanofi Pasteur was transitioning vaccine production to a newer facility that is set to open in 2018, but a manufacturing issue resulted in the loss of a large number of vaccine doses. The company instituted ordering restrictions for YF-VAX to extend the existing supply; however, Sanofi Pasteur alerted the CDC in the spring of 2016 that a supply depletion would likely occur later in the year. Although the company was able to produce additional vaccine doses for 2016, the supply remains insufficient to cover the anticipated demand during the time between closing the old facility and opening the new one.

In the MMWR, Mark D. Gershman, MD, of the CDC’s Division of Global Migration and Quarantine, and colleagues reported that most people infected with yellow fever are asymptomatic. However, the case-fatality rate ranges from 20% to 50% among the estimated 15% of people who develop severe disease. Therefore, the CDC and Sanofi Pasteur are working on a plan to distribute limited quantities of Stamaril until production of YF-VAX resumes at Sanofi Pasteur’s new facility to prevent infections among international travelers who are recommended and sometimes required to receive the vaccine before visiting endemic countries. The distribution of Stamaril in the U.S. was authorized by the FDA in October 2016 through an expanded access investigational new drug application submitted by Sanofi Pasteur.

“Stamaril uses the same vaccine substrain 17D-204 as YF-VAX, and has comparable safety and efficacy,” Gershman and colleagues wrote. “Stamaril has been licensed and distributed in approximately 70 countries worldwide since 1986.”

Sanofi Pasteur and the CDC selected certain sites where Stamaril will be offered, including those that administered a high number of yellow fever vaccine doses to international travelers in 2016, and smaller-volume sites to ensure access in every state and U.S. territory. Sanofi Pasteur is currently recruiting and communicating with selected sites. The company will train staff at the participating sites via webinar in April and May.

“Although the systematic site selection process for the distribution of Stamaril took into account site volume (giving preference to larger sites) and adequate geographic reach, accessibility difficulties for some international travelers might occur, because of the decrease in the number of clinics nationwide that provide yellow fever vaccination from 4,000 to 250,” Gershman and colleagues wrote. “CDC and Sanofi Pasteur will monitor for critical gaps in vaccine access and collaborate to address any issues, including considering the possibility of recruiting additional clinics to participate as necessary.” – by Stephanie Viguers

The CDC announced today that it is anticipating a complete depletion of the U.S. supply of YF-VAX — the only yellow fever vaccine licensed in the United States — by mid-2017.

In response, the CDC is collaborating with the vaccine’s manufacturer, Sanofi Pasteur, to distribute limited quantities of another yellow fever vaccine, Stamaril (Sanofi Pasteur France), that is not licensed in the U.S. However, the number of sites that will offer the vaccine will be significantly fewer than the number of sites that usually distribute YF-VAX.

According to an MMWR, the supply depletion of YF-VAX began in November 2015. Sanofi Pasteur was transitioning vaccine production to a newer facility that is set to open in 2018, but a manufacturing issue resulted in the loss of a large number of vaccine doses. The company instituted ordering restrictions for YF-VAX to extend the existing supply; however, Sanofi Pasteur alerted the CDC in the spring of 2016 that a supply depletion would likely occur later in the year. Although the company was able to produce additional vaccine doses for 2016, the supply remains insufficient to cover the anticipated demand during the time between closing the old facility and opening the new one.

In the MMWR, Mark D. Gershman, MD, of the CDC’s Division of Global Migration and Quarantine, and colleagues reported that most people infected with yellow fever are asymptomatic. However, the case-fatality rate ranges from 20% to 50% among the estimated 15% of people who develop severe disease. Therefore, the CDC and Sanofi Pasteur are working on a plan to distribute limited quantities of Stamaril until production of YF-VAX resumes at Sanofi Pasteur’s new facility to prevent infections among international travelers who are recommended and sometimes required to receive the vaccine before visiting endemic countries. The distribution of Stamaril in the U.S. was authorized by the FDA in October 2016 through an expanded access investigational new drug application submitted by Sanofi Pasteur.

“Stamaril uses the same vaccine substrain 17D-204 as YF-VAX, and has comparable safety and efficacy,” Gershman and colleagues wrote. “Stamaril has been licensed and distributed in approximately 70 countries worldwide since 1986.”

Sanofi Pasteur and the CDC selected certain sites where Stamaril will be offered, including those that administered a high number of yellow fever vaccine doses to international travelers in 2016, and smaller-volume sites to ensure access in every state and U.S. territory. Sanofi Pasteur is currently recruiting and communicating with selected sites. The company will train staff at the participating sites via webinar in April and May.

“Although the systematic site selection process for the distribution of Stamaril took into account site volume (giving preference to larger sites) and adequate geographic reach, accessibility difficulties for some international travelers might occur, because of the decrease in the number of clinics nationwide that provide yellow fever vaccination from 4,000 to 250,” Gershman and colleagues wrote. “CDC and Sanofi Pasteur will monitor for critical gaps in vaccine access and collaborate to address any issues, including considering the possibility of recruiting additional clinics to participate as necessary.” – by Stephanie Viguers

We have known for a while that there was a worldwide shortage of yellow fever vaccine. This has come up during the outbreak in Angola and the current outbreak in Brazil.

We have not seen Yellow Fever in the U.S. in a very long time, but we do have many people who travel to locations that require a vaccine, and we also have the mosquito that transmits the disease, so it is technically possible for an outbreak to occur in the U.S.

Rebecca Katz, PhD, MPH

Associate professor of international healthCo-director, Center for Global Health Science and Security at Georgetown University